NCT05065736

Using a PET Imaging Agent, 18F-Clofarabine (CFA), to Measure Deoxycytidine Kinase Activity in Metastatic Cancer

18F-Clofarabine (CFA) as a PET Imaging Agent to Measure Deoxycytidine Kinase (DCK) Activity in Metastatic Cancer, as a Candidate Predictive Biomarker for Response to DCK-dependent Drugs Such as Gemcitabine

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: Roberto Vargas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether a new type of imaging study, called 18F-Clofarabine (CFA) PET/CT, can be used to image cancer pyrimidine metabolism in participants. PET (positron emission tomography) imaging is a way of looking at cancers that can reveal cancer metabolism. Presently, however, there are no imaging agents in routine use to look at an aspect of cancer metabolism (pyrimidine metabolism) that dictates whether certain cancer drugs, e.g., gemcitabine, are likely to be taken into the cancer cells. This clinical trial will be testing whether 18F-Clofarabine (CFA) could be an imaging agent to measure this aspect of cancer metabolism.

Detailed description

The participants will receive a CFA injection into a vein in their arm. The imaging drug is attracted to and taken into certain cells in the body, including cancer cells. 18F-Clofarabine (CFA) is experimental because it is not approved by the Food and Drug Administration (FDA). The participants will be observed for side effects, and about 1 hour later, they will receive a PET/CT scan. Additionally, they will be contacted the next day to inquire again about any side effects. If the participant's routine care involves repeat imaging of cancer, then the CFA PET/CT scan will be repeated at that time, which could be up to 365 days after the first CFA PET/CT scan.

Conditions

• Metastatic Cancer
• Carcinoma
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	18F-Clofarabine	The participants enrolled will receive a baseline CFA PET/CT evaluation. Then, the participants will undergo the routine follow up would normally occur for their cancer and its treatment. If this routine follow up and care involves repeat imaging of the cancer, then the CFA PET/CT scan will be repeated at that time (timed according to standard-of-care follow-up imaging), which is expected between a month to about 4 months after the first CFA PET/CT scan. The study period will end 24 hours after this repeat PET/CT scan.

Timeline

• Start date: 2023-03-06
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-10-04
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study